Summary of NIH-Specific Amendments to Conflict of Interest Ethics Regulations

The Department of Health and Human Services has evaluated the February
3, 2005, supplemental standards of ethical conduct regulations for NIH employees,
and has made certain revisions. Three principles guided the crafting of
these changes:

The public must be assured that research decisions made at NIH are based
on scientific evidence and not by inappropriate influences.

Senior management and people who play an important role in research
decisions must meet a higher standard of disclosure and divestiture than
people who are not decision-makers.

To advance the science and stay on the cutting edge of research, NIH
employees must be allowed interaction with professional associations,
participation in public health activities, and genuine teaching opportunities.

Here is a summary of the revised regulations:

Divestiture of prohibited financial interests

Senior employees1 (and
their spouses and minor children) may not retain:

an aggregate interest in a substantially affected organization
(SAO)2 in excess of $15,000;

Other NIH employees continue to be subject to government-wide
laws that require divestiture in cases where it is reasonably
necessary to resolve a conflict of interest with the employee’s
official duties but will not be subject to a blanket prohibition.

Disclosure of financial interests

Employees who file either a Public (SF 278) or Confidential
(OGE 450) Financial Disclosure Report and those non-filers who
serve as clinical investigators identified on an NIH clinical
study are required to report the value of any interest in a SAO.

Employees who do not meet these criteria are generally not
required to disclose interests in SAOs.

Outside Activities

Unless an exception applies, NIH employees may not:

engage in employment with a SAO, supported research institution,
or healthcare provider or insurer;

engage in a self-employed business activity with these types
of organizations; or

teach, speak, write, or edit for compensation for these types
of organizations.

Employment with related trade, professional, or similar associations;
on data and safety monitoring boards; in relation to a Grand
Rounds program; as a lecturer in an established course; or on
grant or scientific review committees is generally permissible
with prior approval. Previously established exceptions to the
broad prohibitions remain: teaching a course that requires multiple
lectures; clinical practice; writing or editing for a peer-reviewed
journal; and presenting a CME or CME-like lecture.

Outside employment that involves manual or unskilled labor,
hobbies, artistic endeavors, or interests unrelated to the health
and scientific research of the NIH, such as retail sales, coaching
a youth team, scouting activities, clerical work, and building
trades are generally permissible without prior approval unless
the outside entity is a prohibited source.

However, if the source of the award can be affected by the
employee’s duties or those of any subordinates, gifts valued
in excess of $200 may not be accepted.

Training

Employees are advised that government and HHS-wide conflict of interest laws
and regulations continue to apply in addition to the NIH-specific provisions,
and that each employee will be required to receive ethics training in 2005.
1. Senior employees include the NIH Director and Deputy
Director, senior staff within the Office of the Director that report directly
to the NIH Director; the Directors, Deputy Directors, Scientific Directors, and
Clinical Directors of each Institute and Center within NIH; Extramural Program
Officials who report directly to an Institute or Center Director; and equivalent
employees.

2. Substantially affected organization means: a) a biotechnology
or pharmaceutical company; a medical device manufacturer; or a corporation, partnership,
or other enterprise or entity significantly involved, directly or through subsidiaries,
in the research, development, or manufacture of biotechnological, biostatistical,
pharmaceutical, or medical devices, equipment, preparations, treatments, or products;
b) any organization a majority of whose members are of this type; and c) any
other organization determined by the designated agency ethics official or designee
to be substantially affected by NIH’s programs, policies, or operations.